CMS Manual System · CMS Manual System Department of Health ... 2004 Germaine Laboratories, Aimstep H. pylori {whole blood} ... 2005 Wampole Laboratories Clearview H. pylori II {finger

CMS Manual System

Department of Health & Human Services

Pub 100-04 Medicare Claims Processing

Centers for Medicare & Medicaid Services

Transmittal 642 Date: August 5, 2005

Change Request 3984

SUBJECT: New Waived Tests I. SUMMARY OF CHANGES: This instruction informs contractors of new waived tests approved by the Food and Drug Administration under Clinical Laboratory Improvement Amendments of 1988. Since these tests are marketed immediately after approval, the Centers for Medicare & Medicaid Services must notify its contractors of the new tests so that the contractors can accurately process claims. NEW/REVISED MATERIAL : EFFECTIVE DATE : October 01, 2005 IMPLEMENTATION DATE : October 03, 2005 Disclaimer for manual changes only: The revision date and transmittal number apply only to red italicized material. Any other material was previously published and remains unchanged. However, if this revision contains a table of contents, you will receive the new/revised information only, and not the entire table of contents. II. CHANGES IN MANUAL INSTRUCTIONS: (N/A if manual is not updated) N/A R = REVISED, N = NEW, D = DELETED – Only One Per Row.

R/N/D Chapter / Section / SubSection / Title III. FUNDING: No additional funding will be provided by CMS; Contractor activities are to be carried out within their FY 2006 operating budgets. IV. ATTACHMENTS: Recurring Notification Form

*Unless otherwise specified, the effective date is the date of service.

Attachment – Recurring Update Notification Pub. 100-04 Transmittal: 642 Date: August 5, 2005 Change Request 3984 SUBJECT: New Waived Tests I. GENERAL INFORMATION A. Background: The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations require a facility to be appropriately certified for each test performed. To ensure that Medicare & Medicaid only pay for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver, laboratory claims are currently edited at the CLIA certificate level. Listed below are the latest tests approved by the Food and Drug Administration as waived tests under the CLIA. The Current Procedural Terminology (CPT) codes for the following new tests must have the modifier QW to be recognized as a waived test. However, the tests mentioned on the first page of the attached list (i.e., CPT codes: 81002, 81025, 82270, G0107, 82962, 83026, 84830, 85013, and 85651) do not require a QW modifier to be recognized as a waived test.

CPT Code/Modifier Effective Date Description 86318QW December 9, 2004 Germaine Laboratories, Aimstep H. pylori

{whole blood} 87807QW January 28, 2005 Binax Now RSV Test (K032166/A005) 81003QW February 18, 2005 Physician Sales & Service, Inc. PSS

Select Urine Analyzer 87880QW March 8, 2005 McKesson Medi-Lab Performance Strep

A Test Dipstick 86308QW March 8, 2005 Clearview Mono-Plus II 86318QW March 8, 2005 Wampole Laboratories Clearview H.

pylori II {finger stick or whole blood} 87899QW March 16, 2005 Genzyme OSOM Trichomonas Rapid

Test 86308QW March 16, 2005 McKesson Medi-lab Performance

Infectious Mononucleosis Test 83721QW March 25, 2005 Polymer Technology Systems Cardiochek

PA Analyzer 87880QW April 21, 2005 Biotechnostix Rapid Response Strep A

Rapid Test Strip 87880QW April 21, 2005 Biotechnostix Rapid Response Strep A

Rapid Test Device 87880QW April 21, 2005 RAC Medical Clarity Strep A Rapid Test

Strips

80101QW June 3, 2005 Acon One Step Multi-Drug, Multi-Line Screen Test Device (Professional Use)

The new waived code, 83721QW, has been assigned for LDL cholesterol testing performed using the Polymer Technology Systems Cardiochek PA Analyzer. The new waived code, 87899QW, has been assigned for Trichomonas testing performed using the Genzyme OSOM Trichomonas Rapid Test. B. Policy: The CLIA regulations require a facility to be appropriately certified for each test performed. To ensure that Medicare and Medicaid only pay for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver, laboratory claims are currently edited at the CLIA certificate level. II. BUSINESS REQUIREMENTS “Shall" denotes a mandatory requirement "Should" denotes an optional requirement Requirement Number

Requirements Responsibility (“X” indicates the columns that apply)

Shared System Maintainers

FI

RHHI

Car r ier

DMERC

F I SS

MCS

VMS

CWF

Other

3984.1 The Medicare contractor shall include the new tests listed above in CLIA-covered code files with the QW modifier.

X

3984.2 The Medicare contractor shall permit the use of the code 87899QW for claims submitted by facilities with a valid current CLIA certificate of waiver with dates of services on or after March 16, 2005.

X X

3984.3 The Medicare contractor shall permit the use of the code 83721QW for claims submitted by facilities with a valid current CLIA certificate of waiver with dates of services on or after March 25, 2005.

X X

Requirement Number



FI

RHHI

Car r ier

DMERC

F I SS

MCS

VMS

CWF

Other

3984.4 Contractors need not search their files to either retract payment or retroactively pay claims, however, contractors should adjust claims if they are brought to their attention.

X

III. PROVIDER EDUCATION

Requirement Number



FI

RHHI

Car r ier

DMERC

F I SS

MCS

VMS

CWF

Other

3984.5 A Medlearn Matters provider education article related to this instruction will be available at www.cms.hhs.gov/medlearn/matters shortly after the CR is released. You will receive notification of the article release via the established "medlearn matters" listserv. Contractors shall post this article, or a direct link to this article, on their Web site and include information about it in a listserv message within one week of the availability of the provider education article. In addition, the provider education article must be included in your next regularly scheduled bulletin. Contractors are free to supplement Medlearn Matters articles with localized information that would benefit their provider community in billing and administering the Medicare program correctly.

X

IV. SUPPORTING INFORMATION AND POSSIBLE DESIGN CONSIDERATIONS

A. Other Instructions: The attachment contains the complete list of waived tests, including the new waived tests listed previously. In the attachment, the information in the "Use" column explains the purpose of the waived test. If denial is appropriate, this explanation is unacceptable to use as the reason for the denial of a claim. Use the appropriate remittance advice message that describes why the test was denied. X-Ref Requirement # Instructions

B. Design Considerations: N/A X-Ref Requirement # Recommendation for Medicare System Requirements

C. Interfaces: N/A D. Contractor Financial Reporting /Workload Impact: N/A E. Dependencies: N/A F. Testing Considerations: N/A IV. SCHEDULE, CONTACTS, AND FUNDING Effective Date*: October 1, 2005 Implementation Date: October 3, 2005 Pre-Implementation Contact(s): Kathy Todd (410) 786-3385 Post-Implementation Contact(s): Kathy Todd (410) 786-3385

No additional funding will be provided by CMS; Contractor activities are to be carried out within their FY 2005 operating budgets.

*Unless otherwise specified, the effective date is the date of service. Attachment

TESTS GRANTED WAIVED STATUS UNDER CLIA

This list includes updates from Change Request 3984

CPT CODE(S)

TEST NAME

MANUFACTURER

USE

81002 Dipstick or tablet reagent urinalysis – non-automated for bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen

Various Screening of urine to monitor/diagnose various diseases/conditions, such as diabetes, the state of the kidney or urinary tract, and urinary tract infections

81025

Urine pregnancy tests by visual color comparison

Various

Diagnosis of pregnancy

82270 G0107 (Contact your Medicare carrier for claims instructions.)

Fecal occult blood

Various

Detection of blood in feces from whatever cause, benign or malignant (colorectal cancer screening)

82962

Blood glucose by glucose monitoring devices cleared by the FDA for home use

Various

Monitoring of blood glucose levels

83026

Hemoglobin by copper sulfate – non-automated

Various

Monitors hemoglobin level in blood

84830

Ovulation tests by visual color comparison for human luteinizing hormone

Various

Detection of ovulation (optimal for conception)

85013

Blood count; spun microhematocrit

Various

Screen for anemia

85651

Erythrocyte sedimentation rate – non-automated

Various

Nonspecific screening test for inflammatory activity, increased for majority of infections, and most cases of carcinoma and leukemia


This list includes updates from Change Request 3984 2

CPT CODE(S)

TEST NAME

MANUFACTURER

USE

80101QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.)

1. Phamatech At Home Drug Test (Model 9063)

Phamatech Screening test for the presence/detection of amphetamine in urine

2. Phamatech QuickScreen One Step Amphetamine Test

Phamatech


1. Accu-Stat Drugs of Abuse Home Test for Marijuana (THC)

Accu-Stat Diagnostics, Inc. Screening test for the presence/detection of cannabinoids (THC) in urine

2. ADC CLIA Waived Marijuana (THC) Test

Advantage Diagnostics Corporation (ADC)


Phamatech

4. Phamatech At Home Drug Test (Model 9078T)

Phamatech

5. Worldwide Medical Corporation, First Check® Home Drug Test (THC)

Worldwide Medical Corporation



Phamatech Screening test for the presence/detection of cocaine metabolites in urine

2. Phamatech At Home Drug Test (Model 9073T)

Phamatech

3. Phamatech QuickScreen One Step Cocaine Screening Test

Phamatech

* Newly added waived test system



CPT CODE(S)

TEST NAME

MANUFACTURER

USE



Phamatech Screening test for the presence/detection of methamphetamines in urine

2. Phamatech QuickScreen One Step Methamphetamine Test

Phamatech


DynaGen NicCheck I Test Strips Dynagen, Inc.

Detects nicotine and/or its metabolites in urine, which is used as an aid in indicating the smoking status of an individual and as an aid in the identification of a smoker as a low or high nicotine consumer



Phamatech Screening test for the presence/detection of opiates in urine

2. Phamatech QuickScreen One Step Opiate Screening Test

Phamatech



Phamatech Screening test for the presence/detection of phencyclidine in urine

2. Phamatech QuickScreen One Step PCP Screening Test

Phamatech




CPT CODE(S)

TEST NAME

MANUFACTURER

USE


1. Accu-Stat Drugs of Abuse Home Test for Marijuana (THC) and Cocaine (COC)

Accu-Stat Diagnostics, Inc. Screening test for the presence/detection of cannabinoids (THC) and cocaine metabolites in urine

2. Advantage Diagnostics Advantage Marijuana (THC) and Cocaine Home Drug Test

ADC

3. ADC CLIA Waived Marijuana (THC) and Cocaine Test

ADC

4. Forefront Diagnostics Drugfree@Home THC/COC Test Kit

Forefront Diagnostics, Inc.

5. Worldwide Medical Corporation, First Check® Home Drug Test (THC-COC)



1. ADC CLIA Waived Multiple Drug Test Card

ADC Screening test for the presence/detection of cannabinoids (THC), cocaine metabolites, methamphetamines, opiates, and phencyclidine (PCP) in urine

2. Advantage Diagnostics Corporation ADC Multiple Drug Test Card

Advantage Diagnostics Corporation

3. Alatex Scientific Peace of Mind Multiple Drugs of Abuse Test

Advantage Diagnostics Corporation


Phamatech At Home Drug Test (Model 9150T)

Phamatech Screening test for the presence/detection of amphetamines, cannabinoids (THC), cocaine metabolites, methamphetamines, and opiates in urine


mailto:Drugfree@Home



CPT CODE(S)

TEST NAME

MANUFACTURER

USE


Worldwide Medical Corporation, First Check® Home Drug Test Panel 4 (THC-COC-OPI-MET)


Screening test for the presence/detection of cannabinoids (THC), cocaine metabolites, opiates and methamphetamines in urine


1. Accu-Stat Drugs of Abuse Home Test for Marijuana, Cocaine, Amphetamine, Methamphetamines, Opiates and Phencyclidine

Accu-Stat Diagnostics, Inc. Screening test for the presence/detection of amphetamines, cannabinoids (THC), cocaine metabolites, methamphetamines, opiates, and phencyclidine in urine

2. Acon One Step Multi-Drug, Multi-Line Screen Test Device (Professional Use)*

Acon Laboratories, Inc.


Branan Medical Corporation Fastect II Drug Screen Dipstick Test

Branan Medical Corporation Screening test for the presence/detection of amphetamines, barbiturates, benzodiazeprines, cannabinoids (THC), cocaine metabolites, methadone, methamphetamines, methylenedioxymethamphetamine, opiates, oxycodone, phencyclidine and tricyclic antidepressants in urine

81002, 82570QW

1. Bayer Multistick Pro 7G Reagent Strips

Bayer Diagnostics Screening of urine to monitor/diagnose various diseases/conditions, such as diabetes, the state of the kidney or urinary tract, and urinary tract infections and semi-quantitative measurement of creatinine in urine for the detection of patients at risk for developing kidney damage

2. Bayer Multistick Pro 10LS Reagent Strips

Bayer Diagnostics

3. Bayer Multistick Pro 11 Reagent Strips

Bayer Diagnostics

81003QW 1. Bayer Clinitek 50 Urine Chemistry

Analyzer – qualitative dipstick for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, leukocytes - automated

Bayer

Screening of urine to monitor/diagnose various diseases/conditions, such as diabetes, the state of the kidney or urinary tract, and urinary tract infections




CPT CODE(S)

TEST NAME

MANUFACTURER

USE

81003QW (cont.) 2. Biosys Laboratories Optima Urine Anlayzer

Biosys Laboratories Screening of urine to monitor/diagnose various diseases/conditions, such as diabetes, the state of the kidney or urinary tract, and urinary tract infect

3. Chemstrip Mini UA – qualitative dipstick for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, leukocytes – automated

Boehringer Mannheim Corporation

4. Hypoguard Diascreen® Urine Chemistry Analyzer

Hypoguard USA, Inc.

5. Physician Sales & Service, Inc. PSS Select Urine Analyzer*

Biosys Laboratories, Inc.

6. Roche Diagnostics Urisys 1100 Urine Analyzer

Roche Diagnostics Corp.

7. Roche Diagnostics/Boehringer Mannheim Chemstrip 101 Urine Analyzer

Roche Diagnostics/Boehringer MannheimCorporation

8. Teco Diagnostics URITEK TC-101 Urine Strip Reader

Teco Diagnostics

9. ThermoBiostar™ PocketChem™ UA

ThermoBiostar™

81007QW Diatech Diagnostics Uriscreen (for OTC use)

Savyon/USA Detects catalase in urine which is associated with urinary tract infections (UTIs). White blood cells and some bacteria associated with UTIs are positive for catalase.

82010QW PTS Bioscanner (for OTC use) - for blood ketones

Polymer Technology Systems, Inc.

Measures ketones in whole blood

82010QW, 82962

1. Abbott Laboratories, Medisense Products Precision™ Xtra™ Advanced Diabetes Management System (K983504)

Abbott Laboratories, Inc.

Monitoring of blood glucose levels and measures ketones in whole blood

2. Abbott Medisense Precision Xtra Advanced Diabetes Management System (K040814)

Abbott Laboratories, Inc




CPT CODE(S)

TEST NAME

MANUFACTURER

USE

82044QW, 82570QW

1. Bayer Clinitek 50 Urine Chemistry Analyzer - for microalbumin, creatinine

Bayer Corp. Semi-quantitative measurement of microablumin and creatinine in urine for the detection of patients at risk for developing kidney damage

2. Bayer Diagnostics/ MICROALBUSTIX™ Reagent Strip

Bayer Inc.


1. OraSure Technologies Q.E.D. A-150 Saliva Alcohol Test

OraSure Technologies, Inc. Quantitative determination of alcohol (ethanol) in saliva

2. OraSure Technologies Q.E.D. A-350 Saliva Alcohol Test

OraSure Technologies, Inc.

3. STC Diagnostics Q.E.D. A150 Saliva Alcohol Test

STC Technologies Inc.

4. STC Diagnostics Q.E.D. A350 Saliva Alcohol Test

STC Technologies Inc.

82120QW, 83986QW

1. Litmus Concepts FemExam TestCard (from vaginal swab)

Litmus Concepts, Inc. Qualitative test of a vaginal fluid sample for elevated pH (pH greater than or equal to 4.7) and the presence of volatile amines

2. Quidel QuickVue Advance pH and Amines Test

Quidel Corporation

82273QW 1. Aerscher Hemaprompt FG Aerscher Diagnostics Rapid screening test to detect the presence of gastric occult blood 2. SmithKline Gastroccult SmithKline 82273QW, 83986QW

Beckman Coulter Primary Care Diagnostics Gastrocult®

Beckman Coulter, Inc. Rapid screening test to detect the presence of gastric occult blood and determine the pH (acid-base balance) of gastric aspirates

82274QW G0328QW

1. Beckman Coulter Hemoccult ICT Beckman Coulter, Inc. Detection of blood in feces from whatever cause, benign or malignant (colorectal cancer screening) by immunoassay

2. Enterix InSure™ Fecal Occult Blood Test

Enterix, Inc.

3. Enterix InSure Fecal Immunochemical Test

Enterix, Inc.




CPT CODE(S)

TEST NAME

MANUFACTURER

USE

82465QW (Contact your Medicare carrier for claims instructions.)

1. Advanced Care Johnson & Johnson

Cholesterol monitoring

2. Boehringer Mannheim Accu-Chek InstantPlus Cholesterol

Boehringer Mannheim

3. ChemTrak AccuMeter ChemTrak 4. ENA.C.T Total Cholesterol Test ActiMed Laboratories, Inc. 5. ActiMed Laboratories ENA.C.T.

Total Cholesterol Test (PDU) ActiMed Laboratories, Inc.

6. Lifestream Technologies Cholesterol Monitor

Lifestream Technologies, Inc.

7. Lifestream Technologies Personal Cholesterol Monitor

Lifestream Technologies, Inc.

8. Polymer Technology Systems (PTS) MTM Bioscanner 1000 (for OTC use) for cholesterol


9. PTS Bioscanner Test Strips Chloesterol


82465QW (Contact your Medicare carrier for claims instructions.), 83718QW, 84478QW, 80061QW

1. Piccolo Point of Care Chemistry Analyzer (Lipid Panel Reagent Disc) (Whole Blood)

Abaxis, Incorporated Measures total cholesterol, HDL cholesterol, and triglycerides in whole blood

2. Polymer Technology Systems CardioChek PA Analyzer {PTS Panels Lipid Panel Test Strips}





CPT CODE(S)

TEST NAME

MANUFACTURER

USE

82465QW (Contact your Medicare carrier for claims instructions.), 82962

Polymer Technology Systems Cardiochek PA Analyzer (PTS Panels Chol + Glu Test Panel)


Measures total cholesterol and monitors blood glucose levels

82465QW (Contact your Medicare carrier for claims instructions.), 83718QW, 84478QW, 82947QW, 82950QW, 82951QW, 82952QW, 80061QW

Cholestech LDX Cholestech Measures total cholesterol, HDL cholesterol, triglycerides, and glucose levels in whole blood

82523QW Ostex International Osteomark NTX Point of Care Prescription Home Use

Ostex International Inc. Measures normalized cross-linked N-telopeptides of type 1 collagen in urine

82679QW (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions.), 83002QW

Clearplan Easy Fertility Monitor (for luteinizing hormone and estrone 3 glucuronide)

Unipath Limited Detection of luteinizing hormone and estrone 3 glucuronide in urine to identify the optimal time for conception

82947QW, 82950QW, 82951QW, 82952QW

1. HemoCue B-Glucose Photometer HemoCue Measures glucose levels in whole blood

2. HemoCue® Glucose 201 Microcuvettes and Glucose 201 Analyzer

HemoCue, Inc.

82985QW LXN Fructosamine Test System LXN Corporation Used to evaluate diabetic control, reflecting diabetic control over a 2-3 week period (Not a useful test for screening diabetes mellitus)




CPT CODE(S)

TEST NAME

MANUFACTURER

USE

82962, 82985QW

1. LXN Duet Glucose Control Monitoring System

LXN Corporation Monitoring of blood glucose levels and measures fructosamine, which is used to evaluate diabetic control, reflecting diabetic control over a 2-3 week period

2. LXN IN CHARGE Diabetes Control System

LXN Corporation

83001QW 1. Acon Laboratories, Inc. FSH Menopause Predictor Test

Acon Laboratories, Inc. Detects follicle stimulating hormone in urine

2. Applied Biotech, Inc. RU25 Plus FSH Menopause Test

Applied Biotech, Inc.

3. Genua Menopause Monitor Test Genua 1944 Inc 4. Synova Healthcare MenocheckPro

(Professional Use) Applied Biotech, Inc.

83036QW 1. Bayer DCA 2000 – glycosylated hemoglobin (Hgb A1c)

Bayer Measures the percent concentration of hemoglobin A1c in blood, which is used in monitoring the long-term care of people with diabetes

2. Bayer DCA 2000+ - glycosylated hemoglobin (Hgb A1c)

Bayer Corp.

3. Bio-Rad Micromat II Hemoglobin A1c Prescription Home Use Test

Bio-Rad Laboratories

4. Cholestech GDX A1C Test (Prescription Home Use)

Cholestech Corporation

5. Metrika A1c Now™ - Professional Use (K000887)

Metrika, Inc.

6. Metrika A1c Now for Prescription Home Use (K020234)

Metrika, Inc.

7. Metrika A1c Now for Professional Use (K020235)

Metrika, Inc.

8. Metrika DRx® HbA1c (Professional Use Test System)

Metrika, Inc.

9. Provalis Diagnostics Glycosal™ HbA1c Test

Provalis Diagnostics Ltd.




CPT CODE(S)

TEST NAME

MANUFACTURER

USE

83036QW (cont.) 10. Provalis Diagnostics In2it In-Office Analyzer (II) A1C Prescription Home Use Test System

Provalis Diagnostics Ltd Measures the percent concentration of hemoglobin A1c in blood, which is used in monitoring the long-term care of people with diabetes

83518QW 1. Beckman Coulter ICON Microalb Beckman Coulter Determination of low concentrations of albumin in urine by immunoassay, which is helpful for early detection in patients at risk for developing renal disease

2. Boehringer Mannheim Chemstrip Micral

Boehringer Mannheim

3. Diagnostic Chemicals ImmunoDip™ Urinary Albumin Test

Diagnostic Chemicals Limited

4. Diagnostic Chemicals ImmunoDip™ Urinary Albumin Screen (Urine Dipstick)

Diagnostic Chemicals Limited (USA)

5. Roche Diagnostics Chemstrip Micral (urine dipstick)

Roche Diagnostics Corporation

83605QW KDK Corporation Lactate Pro System KDK Corporation Quantitative measurement of lactate in whole blood 83718QW

PTS Bioscanner (for OTC use) - for HDL cholesterol


Measures HDL cholesterol in whole blood

83721QW Polymer Technology Systems Cardiochek PA Analyzer*


Measures LDL cholesterol in whole blood

83986QW All qualitative color comparison pH testing - body fluids (other than blood)

Various pH detection (acid-base balance) in body fluids such as semen, amniotic fluid, and gastric aspirates

83986QW FemTek pHEM-ALERT® FemTek, LLC Vaginal pH detection (acid-base balance) 84443QW ThyroTec, Inc. ThyroTest Whole

Blood TSH Test ThyroTes, Inc. Qualitative determination of human thyroid stimulating hormone (TSH) in

whole blood, which is a rapid TSH assay for hypothyroidism screening in adults

84450QW Cholestech LDX Aspartate Aminotransferase (AST)(SGOT)

Cholestech Corporation Quantitative determination of aspartate aminotransferase in whole blood

84460QW Cholestech LDX® Alanine Aminotransferase (ALT) Test

Cholestech Corporation Quantitative determination of alanine aminotransferase in whole blood




CPT CODE(S)

TEST NAME

MANUFACTURER

USE

84478QW

PTS, Inc. Bioscanner 2000 for Triglycerides


Measures triglycerides in whole blood

84703QW Bayer Clinitek 50 Urine Chemistry Analyzer - for HCG, urine

Bayer Corp Diagnosis of pregnancy

85014QW Wampole STAT-CRIT Hct Wampole Laboratories Screen for anemia

85018QW 1. Biosafe Laboratories, Inc., Anemiapro Self Screener

Biosafe Laboratories, Inc. Measures hemoglobin level in whole blood

2. HemoCue Donor Hemoglobin Checker System HemoCue

HemoCue

3. HemoCue Hemoglobin System HemoCue 4. HemoCue Hemoglobin 201+

(Capillary, Venous, Arterial Whole Blood)

HemoCue

5. HemoCue Hemoglobin 201+/HemoCue Hemoglobin Microcuvette System

HemoCue

6. GDS Diagnostics HemoSite Meter

- for hemoglobin GDS Technology, Inc.

7. GDS Technology STAT-Site MHgb Test System

GDS Technology

85610QW (Contact your Medicare carrier for claims instructions.)

1. AvoSure PT System (prescription home use)

Avocet Medical, Inc. Aid in screening for congenital deficiencies of Factors II, V, VII, X; screen for deficiency of prothrombin; evaluate heparin effect, coumadin or warfarin effect; screen for Vitamin K deficiency

2. AvoSure Pro (professional use) Avocet Medical, Inc. 3. CoaguChek PST for Prothrombin

Time Boehringer Mannheim Corporation

4. HemoSense INRatio System HemoSense, Inc.

5. ITC Protime Microcoagulation System for Prothrombin Time

International Technidyne Corporation (ITC)




CPT CODE(S)

TEST NAME

MANUFACTURER

USE

85610QW (cont.) (Contact your Medicare carrier for claims instructions.)

6. International Technidyne ProTime Microcoagulation System (ProTime 3 Cuvette) Prescription Home Use

International Technidyne Corporation

Aid in screening for congenital deficiencies of Factors II, V, VII, X; screen for deficiency of prothrombin; evaluate heparin effect, coumadin or warfarin effect; screen for Vitamin K deficiency

7. International Technidyne ProTime Microcoagulation System (ProTime 3 Cuvette) Professional Use

International Technidyne Corporation

8. Lifescan Harmony™ INR Monitoring System -- Prescription Home Use and Professional Use

Lifescan, Inc.

9. Roche/Boehringer Mannheim CoaguChek System for Professional Use

Roche Diagnostics/ Boehringer Mannheim Corporation

10. Roche Diagnostics Coaguchek PST

Roche Diagnostics

11. Roche Diagnostics Coagu Chek S Systems Test (for prothrombin time)

Roche Diagnostics Corporation

85576QW Accumetrics VerifyNow Aspirin Assay Accumetrics Inc. Qualitative assay to measure platelet aggregation 86294QW 1. Bion Diagnostic Sciences BTA

stat Test (for home use) Bion Diagnostic Sciences, Inc.

Immunoassay for the qualitative detection of bladder tumor associated antigen in urine of persons diagnosed with bladder cancer, and used as an aid in the management of bladder cancer patients

2. Matritech, Inc. NMP22® BladderCheck™ Test for Professional and Prescription Home Use

Maritech, Inc.

86308QW 1. Applied Biotech SureStep Mono Test (whole blood)

Applied Biotech, Inc. Qualitative screening test for the presence of heterophile antibodies in human whole blood, which is used as an aid in the diagnosis of infectious mononucleosis

2. BioStar Acceava Mono Test (whole blood)

Wyntek Diagnostics, Inc.

3. Clearview Mono-plus II* Applied Biotech, Inc.




CPT CODE(S)

TEST NAME

MANUFACTURER

USE

86308QW (cont.) 4. Genzyme Contrast Mono (whole blood)

Genzyme Diagnostics Qualitative screening test for the presence of heterophile antibodies in human whole blood, which is used as an aid in the diagnosis of infectious mononucleosis

5. Genzyme OSOM Mono Test Wyntek Diagnostics, Inc.

6. Jant Accutest Infectious Mononucleosis Test (whole blood)


7. LifeSign UniStep Mono Test (whole blood)

Princeton BioMeditech Corp.

8. McKesson Medi-lab Performance Infectious Mononucleosis Test*


9. Meridian ImmunoCard STAT Mono (for whole blood)


10. Polymedco, Inc. Poly stat Mono Applied Biotech, Inc. 11. Quidel Cards O.S. Mono (for

whole blood) Quidel Corporation

12. Quidel QuickVue+ Infectious Mononucleosis (Whole Blood)

Quidel Corporation

13. Remel RIM® A.R.C. Mono Test Applied Biotech, Inc. 14. Seradyn Color Q Mono (whole

blood) Genzyme Diagnostics

15. Wampole Mono-Plus WB Wampole Laboratories 16. Wyntek Diagnostics OSOM Mono

Test (whole blood) Wyntek Diagnostics, Inc.

17. Wyntek Signify Mono Test Wyntek Diagnostics, Inc. 86318QW 1. Abbott FlexPak HP Test for whole

blood SmithKline Diagnostics, Inc. Immunoassay for rapid, qualitative detection of IgG antibodies specific to

Helicobacter pylori in whole blood

2. Abbott TestPack Plus H. pylori (for whole blood)

Abbott Laboratories

3. Acon® H. pylori Test Device ACON Laboratories, Inc. 4. Applied Biotech SureStep H.

pylori WB Test (whole blood) Applied Biotech, Inc.




CPT CODE(S)

TEST NAME

MANUFACTURER

USE

86318QW (cont.) 5. Beckman Coulter Primary Care Diagnostics Flexsure HP Test for IgG Antibodies to H. Pylori in Whole Blood

Beckman Coulter, Inc. Immunoassay for rapid, qualitative detection of IgG antibodies specific to Helicobacter pylori in whole blood

6. Becton Dickinson Link 2 H. pylori

Rapid Test (for whole blood) Cortecs Diagnostics Limited

7. Cardinal Health SP Brand Rapid Test H. pylori

Applied Biotech Inc.

8. Germaine Laboratories, Aimstep H. pylori {whole blood}*


9. JANT Pharmacal Corp. H. pylori WBTest


10. LifeSign Status H.pylori (for whole blood)

Princeton BioMeditech

11. Meridian BioScience ImmunoCard STAT! H.pylori Whole Blood Test


12. Polymedco, Inc. Poly stat H.pylori Applied Biotech, Inc. 13. QuickVue One-Step H. Pylori Test

for Whole Blood Quidel

14. Quidel QuickVue One-Step H.pylori II Test.

Quidel Corporation

15. Remel RIM® A.R.C. H.pylori Test

Remel

16. SmithKline Diagnostics FlexSure HP Test for IgG Antibodies to H. pylori in Whole Blood

SmithKline Diagnostics, Inc.

17. Trinity Uni-Gold™ H.pylori Trinity BioTech 18. Wampole Laboratories Clearview

H. pylori II {finger stick or whole blood}*

Applied Biotech , Inc.

86618QW Wampole PreVue™ B. burgdorferi Antibody Detection Assay

Wampole Laboratories Qualitative detection of IgG/IgM antibodies to Borrelia burgdorferi (causative agent of Lyme disease) in whole blood




CPT CODE(S)

TEST NAME

MANUFACTURER

USE

86701QW 1. OraSure Technologies OraQuick Rapid HIV-1 Antibody Test

OraSure Technologies, Inc. Qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1)

2. OraSure OraQuick Rapid HIV-1 Antibody Test – fingerstick and venipuncture whole blood

OraSure Technologies, Inc.

3. Trinity Biotech Uni-Gold Recombigen HIV Test (Fingerstick, Venipuncture Whole Blood)

Trinity Biotech

86703QW OraSure OraQuick Advance Rapid HIV-1/2 Antibody Test {oral fluid, fingerstick whole blood and venipuncture whole blood}

OraSure Technologies, Inc. Qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in oral fluid, fingerstick whole blood and venipuncture whole blood specimens

87077QW 1. Ballard Medical Products CLOtest Ballard Medical Products Presumptive identification of Helicobacter pylori in gastric biopsy tissue, which has been shown to cause chronic active gastritis (ulcers)

2. Delta West CLOtest Delta West Tri-Med Specialties

3. GI Supply HP-FAST Mycoscience Labs, Inc. 4. GI Supply, Div. Chek-Med

Systems HP One GI Supply

5. Medical Instruments Corporation Pronto Dry H. pylori

Medical Instruments Corporation

6. Serim Pyloritek Test Kit Serim 87210QW 1. Stesans Maybe?Mom Mini

Ovulation Microscope LEC Associates Detects ferning pattern in saliva which is used in the determination of

ovulation (optimal for conception) 2. O2 Unlimited Donna Ovulation

Tester O2 Unlimited Corp.

87449QW ZymeTx Zstatflu® Test Zymetx, Inc. Qualitative determination of influenza types A and B from throat swab specimens that does not differentiate between types A and B

87804QW Quidel QuickVue® Influenza Test Quidel Corporation Qualitative detection of influenza type A and type B antigens from nasal swab, nasal wash or nasal aspirate specimens that does not differentiate between influenza types A and B




CPT CODE(S)

TEST NAME

MANUFACTURER

USE

87804QW 1. Quidel Quickvue Influenza A+B Test

Quidel Corporation Qualitative detection of influenza type A and type B antigens from nasal swab, nasal wash or nasal aspirate specimens that does differentiate between influenza types A and B

2. BinaxNOW® Influenza A & B Test in nasopharyngeal (NP) swab and nasal wash/aspirate specimens

Binax, Inc.

87804QW Binax Now® Flu A Test Binax, Inc. Qualitative detection of influenza type A antigen in nasal wash and nasopharyngeal swab specimens

87804QW Binax Now® Flu B Test Binax, Inc. Qualitative detection of influenza type B antigen in nasal wash and nasopharyngeal swab specimens

87807QW 1. Binax NOW RSV Test (K021687) Binax, Inc. Rapid immunoassay for the qualitative detection of respiratory syncytial virus antigen

2. Binax NOW RSV Test (K032166/A005)*

Binax, Inc.

3. Integrated Biotechnology Quick Lab RSV Test

Integrated Biotechnology Corp.

87880QW 1. Abbott Signify Strep A Test (from throat swab only)

Wyntek Diagnostics, Inc. Rapidly detects GAS antigen from throat swabs and used as an aid in the diagnosis of GAS infection, which typically causes strep throat, tonsillitis, and scarlet fever

2. Acon® Strep A Rapid Strip Test Acon Laboratories, Inc. 3. Acon® Strep A Twist Rapid Test Acon Laboratories, Inc. 4. Applied Biotech SureStep Strep A

(II) (direct from throat swab) Applied Biotech, Inc.

5. Beckman Coulter ICON DS Strep A Test

Princeton BioMeditech Corp.

6. Beckman Coulter ICON SC Strep A Test

Acon Laboratories, Inc

7. Beckman Coulter Primary Care Diagnostics ICON DS Strep A


8. Beckman Coulter Primary Care Diagnostics ICON FX Strep A Immunochemical Strep A Test

Beckman Coulter




CPT CODE(S)

TEST NAME

MANUFACTURER

USE

87880QW (cont.) 9. Becton Dickinson LINK 2 Strep A Rapid Test (direct from throat swab)

Applied Biotech, Inc. Rapidly detects GAS antigen from throat swabs and used as an aid in the diagnosis of GAS infection, which typically causes strep throat, tonsillitis, and scarlet fever

10. Binax NOW Strep A Test Binax 11. BioStar Acceava Strep A Test

(direct specimen only) Wyntek Diagnostics, Inc.

12. Biotechnostix Rapid Response Strep A Rapid Test Device*

Acon Laboratories Co.

13. Biotechnostix Rapid Response Strep A Rapid Test Strip*


14. Cardinal Health SP Brand Rapid Test Strep A Dipstick

Applied Biotech Inc.

15. DE Healthcare Products, TruView Strep A Test

DE Healthcare Products

16. DE Healthcare Products TruView Strep A Cassette Test


17. Fisher HealthCare Sure-Vue Strep A (direct from throat swab)


18. Genzyme Contrast Strep A (direct from throat swab)

Genzyme Diagnostics

19. Genzyme OSOM® Strep A Ultra Test – 25 Test Kit Size

Genzyme Corporation

20. Genzyme OSOM Ultra Strep A Test

Genzyme General

21. Germaine Laboratories StrepAim Rapid Dipstick Test

Germaine Laboratories, Inc.

22. Germaine Laboratories Strep AIM Tower

Germaine Laboratories, Inc.

23. Henry Schein Inc, One Step+ Strep A Test

Henry Schein

24. Immunostics Detector Strep A Direct





CPT CODE(S)

TEST NAME

MANUFACTURER

USE

87880QW (cont.) 25. Immunostics Immuno/Strep A Detector

Acon Laboratories, Inc Rapidly detects GAS antigen from throat swabs and used as an aid in the diagnosis of GAS infection, which typically causes strep throat, tonsillitis, and scarlet fever

26. Instant Technologies iStrep Strep A


27. Jant Pharmacal AccuStrip Strep A (II) (direct from throat swab)


28. Laboratory Supply Company (LSC) PEP Strep A Cassette Test


29. LSC PEP Strep A Dipstick Test Acon Laboratories Co. 30. LifeSign LLC Status Strep A Princeton BioMeditech 31. Mainline Confirms Strep A Dots

Test (direct from throat swab) Applied Biotech, Inc.

32. McKesson Medi-Lab Performance Strep A Test Dipstick*


33. Meridian Diagnostics ImmunoCard STAT Strep A (direct from throat swab)


34. Polymedco, Inc. Poly stat A (II) Applied Biotech, Inc.

35. Polymedco Poly Stat Strep A Liquid Test

Applied Biotech, Inc

36. QuickVue In-Line One-Step Strep A Test (K934484)

Quidel Corporation

37. QuickVue® Dipstick Strep A Quidel Corporation

38. Quidel QuickVue® In-Line Strep A

Quidel Corporation

39. RAC Medical Clarity Strep A Rapid Test Strips*


40. Remel RIM® A.R.C. Strep A Test Applied Biotech, Inc. 41. SmithKline ICON Fx Strep A Test

(from throat swab only) Binax




CPT CODE(S)

TEST NAME

MANUFACTURER

USE

87880QW (cont.) 42. Stanbio Laboratory E-Z Well Strep A Rapid Device Test

Acon Laboratories Co. Rapidly detects GAS antigen from throat swabs and used as an aid in the diagnosis of GAS infection, which typically causes strep throat, tonsillitis, and scarlet fever

43. Stanbio QuStick Strep A Stanbio Laboratory 44. Wyntek Diagnostics OSOM Strep

A Test Wyntek Diagnostics, Inc

45. Wyntek OSOM® Ultra Strep A Test

Wyntek Diagnostics, Inc.

87899QW Genzyme OSOM Trichmonas Rapid Test*

Genzyme Corp. Qualitative detection of Trichmonas vaginalis from vaginal swabs

89300QW(This test may not be covered in all instances. Contact your Medicare carrier for claims instructions

Embryotech Laboratories FertilMARQ™ Home Diagnostic Screening Test for Male Infertility

Embryotech Laboratories, Inc.

Screening test to measure sperm concentration


CMS Manual System · CMS Manual System Department of Health ... 2004 Germaine Laboratories, Aimstep H. pylori {whole blood} ... 2005 Wampole Laboratories Clearview H. pylori II {finger

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